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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02948530
Other study ID # LUA-74204
Secondary ID
Status Recruiting
Phase
First received October 26, 2016
Last updated April 10, 2018
Start date October 2016
Est. completion date December 2018

Study information

Verified date April 2018
Source Sahlgrenska University Hospital, Sweden
Contact Stefan Lundin, MD, PhD
Phone +46313428112
Email stefan.lundin@gu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. The measurements are performed in sedated and mechanically ventilated patients in the intensive care unit.


Description:

Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly.

In this study values obtained as described in Method 1 above are compared to values obtained with a new method (Method 2) in which a PEEP-step is performed with a size of the lung volume increase which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in sedated and mechanically ventilated patients in the intensive care unit.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Mechanically ventilated patients in the intensive care unit

Exclusion Criteria:

Patients with chronic obstrucive lung disease

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Stefan Lundin

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of lung elastance and transpulmonary pressure Comparison of a new versus the classical method for measurement of transpulmonary pressure Within one hour
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